BEUDAMED
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    SEARE BIOMEDICAL MALAR IMPLANTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STERILE INSTRUMENT DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MUSTANG¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·February 28, 2013

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 6, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 24, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012